BRPI0922307B1 - BLOOD AND CASSETTE BAG SYSTEM - Google Patents

Abstract

blood bag and cassette system the present invention relates to a blood bag system mounted on a centrifugation and separation device, a filter is configurable in different appropriate directions at a time of storage and at a time of use and a first tube, a second tube and the filter are configured, respectively, in appropriate orientations during use. the blood bag system (10a) includes a bc collection bag (54) for centrifuging a buffy coat, the filter (56) for removing white blood cells from a supernatant liquid transferred from the bc collection bag (54), a platelet preservation bag (58) to hold the supernatant liquid that has passed through the filter (56), the first tube (60) connecting to the bc collection bag (54) and an inlet (56a) the filter (56), the second tube (62) connecting to the platelet conservation pouch (58) and an outlet (56b) of the filter (56), a cassette (50a) to be attached to the centrifugation and separation apparatus, a connection (142) to support the filter (56) and a hinge section (140), which can be tilted with respect to the cassette (50a) with reference to an axis in the circumferential direction.

Description

Descriptive Report of the Invention Patent for BLOOD AND CASSETTE BAG SYSTEM.

Technical Field [001] The present invention relates to a blood bag system and a cassette to be mounted in a centrifugation and separation device or similar, for centrifuging whole blood or a blood component (buffy coat or similar ) prepared from whole blood in a supernatant liquid and a sedimentary liquid and transfer of the supernatant liquid.

Background Technique [002] So far, whole blood transfusion in which all blood components obtained through blood donation are subjected to transfusion has been the main line of blood transfusion. Concomitant with recent advances in technology, however, transfusion of blood components has become necessary, in which the blood obtained is divided into blood components, such as red blood cells, platelets and plasma and only the blood component required for a patient is undergoing transfusion. With the transfusion of blood components, it is possible to lighten the load on the patient's circulatory system and other side effects and effective use of donated blood is compromised.

[003] When submitted to centrifugation, the donated blood is divided into a PRP fraction of light supernatant, a heavy sedimentary CRC fraction and a buffy coat (BC) formed between them. The white-platelet layer contains white blood cells, platelets and red blood cells and, in particular, platelets include young active platelets in high proportion.

[004] On the other hand, the buffy coat contains white blood cells and therefore cannot be used as is. In

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2/42 in view of this, it is a common practice to extract only the buffy coat from the centrifuged blood, re-centrifuge it in order to separate the buffy coat in a supernatant liquid and a sedimentary liquid and also remove white blood cells from a supernatant liquid through a white blood cell removal filter (see, for example, Patent Document 1).

Patent Document 1 [005] Japanese Patent Publication Open to Public Inspection

No. 07-507717 (PCT) (W093 / 25295A1).

Summary of the Invention [006] In order to centrifuge the buffy coat in a supernatant liquid and a sedimentary liquid and transfer the supernatant liquid as mentioned above, it is necessary to perform centrifugation in a previous step and separate (transfer) in a later step. Consequently, two special-purpose devices are required for this, with problematic operations.

[007] It is preferable that a centrifugation and separation device, which is capable of carrying out both steps simultaneously, is put into practical use. As such a centrifugation and separation apparatus, a centrifuge and a separation means (transfer medium) can be provided, so a desired treatment will be carried out using a predetermined disposable blood bag system.

[008] For such a blood bag system to be used in the centrifugation and separation device, in general, the following configuration can be considered. The system includes a first pouch in which the buffy coat is collected and in which the buffy coat is centrifuged in a supernatant liquid and a sedimentary liquid, a filter for removing white blood cells from the

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3/42 supernatant liquid transferred by compression of the first bag by a predetermined compression medium, a second bag for collecting the supernatant liquid devoid of white blood cells by the filter, a first tube for connecting the first bag and a filter inlet, a second tube for connecting the second bag and a filter outlet and a first clip and a second clip for closing and opening the first tube and the second tube.

[009] In order to mount such a blood bag system in a centrifugation and separation device, however, the first bag, the second bag and the filter must be disposed in appropriate positions and the first tube, the second tube, the first clamp and the second clamp must be arranged along appropriate paths. This leads to a complicated procedure, as well as a danger of incorrect assembly.

[0010] Furthermore, the filter is preferably arranged in an appropriate orientation, in order to safely remove certain cells, such as white blood cells.

[0011] Furthermore, so that the blood bag system, which was sterilized during its production, is kept in a sterile state, it is assumed that the blood bag system has been kept in an airtight bag during the period of manufacture until use. The packaged blood bag system desirably has as little volume as possible during storage.

[0012] The present invention was made considering the problems mentioned above. Consequently, it is an object of the invention to provide a blood bag system and a cassette for it, in which a filter can be adapted in different appropriate orientations at a time of storage and at a time

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4/42 of use and even where a first tube, a second tube and the filter can, respectively, be arranged in appropriate guidelines at the time of use.

[0013] In accordance with the present invention, a system is provided including a first pouch for collecting whole blood or a blood component, a filter having a filter means for removing predetermined cells from a blood component obtained by means of centrifugation of the blood. liquid contained in the first bag, a second bag for collecting a blood component obtained when removing the predetermined cells by the filter, a first tube for connecting the first bag and a filter outlet, a second tube for connecting the second bag and an outlet of the filter and a cassette having a plate section to support a part of the first tube and a part of the second tube, where the cassette includes a connection to support the filter and a hinge section by which the connection is connected to the plate section in an inclinable way.

[0014] According to the present invention, there is also provided a cassette mounted in a multiple pouch including a first pouch for collecting whole blood or a blood component, a filter having a filter means for removing predetermined cells from a blood component obtained by centrifuging the liquid contained in the first bag, a second bag for collecting a blood component obtained when removing the predetermined cells by the filter, a first tube for connecting the first bag and a filter outlet and a second tube for connecting the second bag and a filter outlet, where the cassette holds a part of the first tube and a part of the second tube and includes a connection to support the filter and a hinge section by which the connection is connected to the plate section of a tilting way.

[0015] With the tilt hinge section thus provided,

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5/42 the connection and the filter can be adapted in different orientations appropriate at the time of storage and at the time of use. In addition, since the first tube and the second tube are preliminarily properly arranged in the blood bag system cassette, it is sufficient to mount the cassette in a predetermined portion of a centrifuge and separation device. Therefore, there is no need for layer formation and intricate configuration of the first and second tubes and assembly can be carried out easily and safely.

[0016] The hinge section can be configured to tilt to assume several states, including an expanded state in which the connection or filter is located substantially on the same plane as the plate section and a curved state in which the connection or the filter is inclined substantially perpendicular to the plate section. This ensures that the cassette and the plate section reside in substantially the same plane in the expanded state, so that the cassette and the plate section can be sufficiently thin during storage and can be folded into a thin form together with the first bag, the second bag and the like. In addition, in the curved state, the filter can be arranged in an appropriate 90 ° curved orientation, while being maintained in a predetermined state when mounted on the cassette plate section.

[0017] The hinge section may have a retainer, whereby the angle of inclination of the connection or of the filter with respect to the plate section is substantially restricted at a right angle. With such a retainer, the filter can be adapted to a more appropriate angle.

[0018] The filter can be provided with an inlet on the first surface side at one end of it and an outlet on the second surface side at the other end of it. The connection can maintain the filter so that, in the curved state, the inlet

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6/42 is located on the outside, while the outlet is located on the inside. This allows the filter to be used in an appropriate orientation.

[0019] The connection may have a first adaptation portion in which the filter inlet is adapted and a second adaptation portion in which the filter outlet is adapted, in which the first adaptation portion is located on the outer side with respect to to the second adaptation portion in the curved state. When the first fitting portion and the second fitting portion mentioned above are arranged, it is prevented that the filter is not mounted incorrectly on the connection.

[0020] The connection can maintain the filter so that the filter outlet is arranged on the proximal side with respect to the hinge portion, while the filter inlet is arranged on a distal side with respect to the hinge portion. This ensures that the filter can be used in an appropriate orientation.

[0021] The cassette may have an arched section for forming a pocket hole in which the first pocket is inserted on the outer side in relation to the plate section, where the hinge section is arranged in the arched section. When such an arc section is provided, it is possible to arrange the connection and the filter on the outer side and to arrange the first bag on the inner side. In the centrifugation and separation apparatus, the first bag is compressed by means of compression during a separation step that occurs after a centrifugation step. In view of this, arrangement of the first pouch on the inner side is preferable.

[0022] It is preferable that whole blood or a blood component collected from a plurality of donors be collected in the first bag, in which the blood bag system is mounted on a centrifugation and separation device for centrifuging the liquid contained

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7/42 in the first bag in a supernatant liquid and a sedimentary liquid, removing a predetermined component of the supernatant liquid through the filter and then transferring the supernatant liquid, devoid of the predetermined component, to the second bag.

[0023] A configuration can be adopted in which the centrifuge and separation apparatus includes a first sensor and a second sensor, each of which has a section that emits light and a section that receives light and which detects the type of liquid that passes between the section that emits light and the section that receives light, the cassette has a sensor hole in which the first sensor and the second sensor are inserted and the first tube is located in order to pass between the section that emits light and the section that receives light from the first sensor, while the second tube is located so as to pass between the section that emits light and the section that receives light from the second sensor. This makes it possible to safely detect the liquids present in the first tube and the second tube.

[0024] In accordance with the blood bag system and the cassette referring to the present invention, the tilting hinge section is provided, which ensures that the connection and the filter can be adapted in different appropriate orientations at the time of storage and in the time of use. In addition, the first tube and the second tube are preliminarily properly arranged in the cassette in the blood bag system, so that it is sufficient to mount the cassette in a predetermined portion of a centrifuge and separation apparatus or the like. Therefore, there is no need for layer formation and intricate configuration of the first and second tubes and their assembly can be carried out easily and safely.

Brief Description of the Drawings [0025] Figure 1 is a perspective view of a centrifuge and separation apparatus;

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8/42 [0026] figure 2 is an enlarged partial perspective view of a centrifugal drum in the centrifugation and separation apparatus;

[0027] figure 3 is an exploded perspective view of an insertion unit;

[0028] figure 4 is a plan view of a blood bag system according to a first embodiment of the present invention;

[0029] figure 5 is a plan view of a system with multiple pockets;

[0030] figure 6 is an enlarged partial plan view of the blood bag system according to the first embodiment;

[0031] figure 7 is an enlarged partial perspective view of the blood bag system according to the first embodiment, in a condition where a filter holder is expanded;

[0032] figure 8 is an enlarged partial perspective view of the blood bag system according to the first embodiment, in a condition where the filter holder is curved at 90 °;

[0033] figure 9 is a perspective view of the proximity of a sensor hole in a cassette;

[0034] figure 10A is a plan view of a first clamp in an initial state, figure 10B is a plan view of the first clamp in a closed state and figure 10C is a plan view of the first clamp during a return movement of the same;

[0035] figure 11 is a perspective view of a hinge section and a cassette tube fitting section;

[0036] figure 12 is an enlarged partial side view of the blood bag system according to the first embodiment, in a condition where the filter holder is expanded (dispersed);

[0037] figure 13 is an exploded perspective view of a filter and a support body;

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9/42 [0038] figure 14 is a schematic illustration of actions performed on the centrifugation and separation apparatus;

[0039] figure 15 is an enlarged partial plan view of a blood bag system according to a second embodiment of the invention;

[0040] figure 16 is an enlarged partial perspective view of the blood bag system according to the second embodiment, in a condition where the filter holder is not curved;

[0041] figure 17 is a plan view of a first clamp operation section; and [0042] figure 18 is an enlarged partial plan view of a blood bag system according to a third embodiment of the invention.

Description of Modalities [0043] A blood bag and the cassette according to the present invention will be described below, in which modalities of the same are shown and described with reference to figures 1 to 18 in annex. [0044] Blood bag systems 10a, 10b, 10c and cassettes

50a, 50b, 50c according to the first to third modalities are, respectively, mounted in a centrifugation and separation apparatus 11 for centrifuging whole blood or a blood component (hereinafter referred to as the buffy coat in the following modalities) prepared from whole blood in a supernatant liquid and a sedimentary liquid and for transferring the supernatant liquid. First, the centrifugation and separation apparatus 11 will be described. In the following description, the direction of arrow A in figure 2 will be taken as a radial direction and the direction of arrow B will be taken as a circumferential direction. Strictly speaking, the circumferential direction is the direction along the circular arc, as indicated by arrow B. For convenience of description, however, a

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10/42 direction orthogonal to arrow A at the location being described will also be referred to as the circumferential direction.

[0045] As shown in figure 1, the centrifugation and separation apparatus 11 has a shape similar to the box and includes a top cover 12 which can be opened and closed, a centrifugal drum (centrifugation means) 14 within the apparatus, its unit insertion holes 16 arranged at regular angular intervals (60 °) inside the centrifugal drum 14, six insertion units 18 inserted, respectively, in the unit insertion holes 16 and six compressors (compression medium) 20 (see figure 2 ) which are provided in a central area and which can be advanced and retracted in a rotational radial direction with respect to the insertion units 18.

[0046] The centrifuge and separation device 11 is operated based on operations carried out in a console section provided in front of the device. In addition, the centrifugation and separation device 11 is controlled by a microcomputer (not shown) and can show predetermined information on a monitor 24.

[0047] As shown in figure 2, a central body 14a of central drum 14 has a containment lever 25, which is driven by an elastic body and which supports an end portion of a cassette holder 38, electrodes 27, first rods 136 and second rods 138 and a compressor 20. The first rods 136 and the second rods 138 are provided in two pairs in which, among these rods, the rods on the first side of the circumferential direction B1 constitute a first means of driving the clamp 17a for closing and opening a first clamp section 106 (see figure 3) and the rods on the second side of the circumferential direction B2 constitute a second clamp drive means 17b for closing and opening a second clamp section

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11/42

108 (see figure 3). The section shown in figure 2 can be configured as a single unit and six such units can be combined with each other along the circumferential direction [0048] As shown in figure 3, the insertion unit 18 has a unit body 26 , a cover body 28 and the blood bag system 10a. The unit body 26 is a tube with a bottom which has a wide circular arc shape in an upper plan view and is open at the top, in which a small chamber (first chamber) 30 on the side of the inner diameter and a large chamber (second chamber) 32 are divided from each other by an arched wall 34. A collection bag of buffy coat (first bag) 54 to be described later is disposed inside the small chamber 30, while a platelet conservation bag (second bag) 58 and a sampling bag 76 are disposed within the large chamber 32. The platelet conservation pouch 58 has a surface area which is enlarged to ensure oxygen permeability appropriate for the platelets collected therein and which it is configured to be larger than the buffy coat collection bag 54.

[0049] The buffy coat collection bag (BC collection bag) 54, the platelet conservation bag 58 and the sampling bag 76 are formed, each, for example, through a method in which elements flexible sheets made of a flexible resin, such as polyvinyl chloride and polyolefin, are deposited on top of each other and sealing portions at the peripheral edges of the sheets are joined by melting (thermal melting, high frequency melting) or adhesion of to obtain a bag-shaped body.

[0050] The small chamber 30 opens not only at the top, but also on the inside diameter side. A filter bag

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12/42 to contain a filter 56 and a connection 142, which will be described later, are provided on the outer diameter side of the wall 34. A cassette holder 38 similar to the plate projecting onto the inner diameter side is provided in both end portions on the inner diameter side of the small chamber 30.

[0051] The cassette holder 38 includes a first sensor 40 and a second sensor 42 for detecting the types of liquids that pass inside a first tube 60 and a second tube 52, both to be described later, as well as separation levers 44 and support projections 45 provided on both ends in the circumferential direction. The first sensor 40 and the second sensor 42 include sections that emit light 40a, 42a (see figure 9) and sections that receive light 40b, 42b (see figure 9), in which the type of liquid that passes between these sections can be determined based on the degree of light transmission through the liquid. The light-emitting sections 40a, 42a and the light-receiving sections 40b, 42b are arranged in parallel with each other and project slightly upward on the upper surface of cassette holder 38. A plurality of contacts (not shown) for connection to the first sensor 40 and the second sensor 42 or to interface with their circuits are provided on a lower surface of the cassette holder 38. When the contacts are placed in contact with the electrodes on the receiving side 27 (see figure 2) provided on the central body 14a of the centrifugal drum 14, signals from the first sensor 40 and the second sensor 42 can be supplied to the microcomputer.

[0052] The cover body 28 includes a cover which is mounted on the unit body 26 from an external side portion thereof. The cover body 28 is capable of covering an external side surface, an upper surface and a lower surface of the unit body 26 and can safely maintain the bag system.

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13/42 blood 10a mounted on the unit body 26.

[0053] Then, the blood bag system 10a and the cassette

50a according to the first modality will be described below. As shown in figure 4, the blood bag system 10a comprises a multiple bag 52 and a cassette 50a.

[0054] As shown in figure 5, the multiple bag 52 includes a BC 54 collection bag in which a buffy coat (blood component) is collected and in which the buffy coat is centrifuged in a supernatant liquid (blood component) and a sedimentary liquid through the centrifuge drum 14, a filter 56 for removing white blood cells (predetermined cells) from the supernatant liquid transferred by compressing the BC 54 collection bag by compressor 20, the platelet conservation bag 58 for collection of the supernatant liquid obtained when removing white blood cells by filter 56, a first tube 60 for connecting the BC collection bag 54 and an inlet 56a of filter 56 and a second tube 62 for connecting the platelet conservation bag 58 and an outlet 56b of filter 56. Filter 56 is preferably provided with a mark on it, which is indicative of the direction of blood flow neo.

[0055] The filter 56 (see figure 13) has a shape similar to the thin plate, approximately elliptical, with the inlet 56a provided on a first surface side on one end of it and the outlet 56b provided on a second surface side on the other end of it. Each of the inlet 56a and the outlet 56b comprises a tubular body, which is elongated in the same direction as the longitudinal direction of the filter 56. Within the filter 56, a flat filter means 57 (see figure 14) is provided for dividing the interior on a first surface side and a second surface side, respectively.

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14/42 [0056] The multiple bag 52 further includes a third tube 70 having a terminal portion to which a container 68 for a platelet preserving liquid can be connected and having the other end of it connected to the BC collection bag 54 , a branched tube 74 which is branched (into six branches, for example, formed through bifurcation and trifurcation) of the third tube 70 and to which a plurality of BC 72 bags can be connected, the sampling bag 76 for sampling the liquid contained in the platelet conservation bag 58, a fourth tube 78 for interconnection of the platelet conservation bag 58 and the sampling bag 76 and a sampling tube 80 that branches off from the fourth tube 78. When the bag system of blood 10a is mounted on the centrifuge and separation device 11, the third tube 70 is cut after melting to prevent leakage in a location close to the BC 54 collection bag. left when cutting forms a third tube 70a (see Figure 7).

[0057] The multiple pouch 52 includes a clip 82 provided in the vicinity of an end portion of the third tube 70, a clip 84 provided on the tip side with respect to the branch portion of the third tube 70, a clip 86 provided in the vicinity of a terminal portion of fourth tube 78 and a clip 88 provided for sampling tube 80. Each of the tubes in the blood bag system 10a is a transparent flexible resin tube.

[0058] Clamps 82, 84, 86, 88 are standard products which have been used until now and the tubes on which they are mounted can be closed and opened by operating clamps 82, 84, 86, 88 with a finger. It is recommended to provide staples 82, 84, 86, 88 with different colors according to their position and / or purpose of use. In times of sterilization and storage of the blood bag system 10a, each

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15/42 of clips 82, 84, 86, 88 is in an open state, so that the interior of the multiple pouch 52 is in a mutually connected and uniformly sterilized state.

[0059] Each of the end portions of the third tube 70, the branched tube 74 and the sampling tube 80 is closed by a predetermined means and is placed in a sterile state obtained when undergoing a predetermined sterilization treatment (for example, irradiation with γ rays) together with cassette 50a.

[0060] Incidentally, although for convenience of illustration it is shown in figure 5 that the BC bag 72 and the container 68 can be connected to the multiple bag 52 lacking the cassette 50a, in practice, the BC 72 bag and the container 68 are connected in a condition where the cassette 50a is provided in the blood bag system 10a (see figure 4), as will be described later.

[0061] Returning to figure 4, the blood bag system 10a includes multiple bag 52 and cassette 50a. Cassette 50a is fitted with the first tube 60 and the second tube 62.

[0062] As shown in figures 6, 7 and 8, cassette 50a includes a plate section 100 to be mounted on cassette holder 38, an arc section 102 for interconnection of both end portions on the outer side of the section of plate on the outer side of the plate section 100 and a filter holder 104 connected to a central portion on the outer diameter side of the arc section 102. The material of the cassette 50a, for example, is PP (polypropylene), POM (polyoxymethylene) or similar.

[0063] The arc section 102 is formatted along the upper end of the wall 34 and the space surrounded by the outer terminal surface of the plate section 100 and the arc section 102 has the same shape as the upper surface portion of the small chamber 30 thereby forming a pocket hole 105 into which to insert the pocket

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16/42 BC collection 54. A portion of the entire length of the arc section 102 can be provided with an angled structure, in order to intensify the resistance.

[0064] The plate section 100 includes the first clamp section

106 and the second clamp section 108 provided on the inner diameter side by means of integral molding, a hole for sensor 110 which is provided in an approximately central portion and into which the first sensor 40 and the second sensor 42 are inserted, a first guide passage 112 to guide the first tube 60, a second guide passage 114 to guide the second tube 62, an auxiliary fixing section 116 for fixing the third short tube

70a and two pins (support sections) 118 provided in an outer end portion.

[0065] The two pins 118 have an appropriate extended tip shape and are inserted into the terminal holes of the BC 54 collection bag, thereby securing the terminal portions of the BC 54 collection bag. The BC 54 collection bag it has a terminal portion fixed by pins 118 and a body portion inserted into pocket hole 105. Each of the pins 118 can have a tip portion divided in two so as to form a narrow groove. Therefore, when fixing the BC 54 collection bag, pins 118 can be inserted into the terminal holes, reducing their diameter in a way that narrows the groove and, after insertion, pins 118 can be returned to their initial state. , in order to produce an effect that prevents sliding.

[0066] The auxiliary fixing section 116 is formed by walls that make slight contact with both side surfaces of the third tube 70a and is shaped so as to curve in the direction of an external diameter of the same, after orienting the third tube 70a in a appropriate amount in the first circumferential direction B1, from

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17/42 an end portion of the inner diameter side of the BC 54 collection bag. This ensures that, over the third tube 70a, only a sufficiently short tip portion protrudes from the plate section 100 (see figures 7 and 8) and the projection direction is outward (i.e., in the centrifugal direction A1), so that the third tube 70a does not vibrate or is moved during centrifugation.

[0067] The first guide passage 112 and the second guide passage

114 each have a groove shape which is formed by walls provided on both sides substantially over the entire length of the same and which is opened on the upper side. The first guide passage 112 and the second guide passage 114 are provided with small projections 117 that prevent sliding in the open upper end portions thereof.

[0068] The first guide passage 112 extends in the direction of the inner diameter from a terminal portion of the BC 54 collection bag, passes through the hole for sensor 110, is curved in the first circumferential direction B1 in the vicinity of a terminal surface on the inside diameter side, immediately after it passes through the first clamp section 106, curved in the direction of the outside diameter in the vicinity of an end portion in the first circumferential direction B1 and reaches an outside diameter end of the plate section 100, where the first guide passage 112 curves internally to point towards filter holder 104.

[0069] The second guide passage 114 extends in the direction of the internal diameter of the hole for sensor 110, is curved in the second circumferential direction B2 in the vicinity of a terminal surface on the side of the internal diameter, passes immediately through the second clamp section 108, it is curved in the direction of the outside diameter in the vicinity of a terminal portion in the second circumferential direction B2 and, after that, it is curved towards an incliPetition side portion 870190089390, of 10/09/2019, pg. 24/57

18/42 nothing.

[0070] As shown in figure 9, in the hole for sensor 110, the first tube 60 and the second tube 62 each have upper surfaces of them fixed stably by two arms 120 having tips curved slightly downwards and extend, respectively , in the radial direction. The first tube 60 and the second tube 62 are arranged in parallel in the circumferential direction, in such a way that the gaps are stuck on both side surfaces in the circumferential direction of the sensor hole 110 and another gap is trapped between the first tube 60 and the second tube 62. When the cassette 50a is mounted on the cassette holder 38, the first sensor 40 and the second sensor 42 are inserted in the clearances in the hole for sensor 110, the first tube 60 is arranged between the section that emits light 40a and the section that receives light 40b and the second tube 62 is disposed between the section that emits light 42a and the section that receives light 42b. The section that receives light 40b and the section that receives light 42b are integrally formed. The first tube 60 and the second tube 62 are supported by the four arms 120, so that they remain stable despite the orientation of the cassette 50a. The gap in the circumferential direction between the two arms 120, which are opposite each other in the circumferential direction, is narrowly formed so that an extension of this first tube 60 and the second tube 62 can pass through the gap in a compressed state down. As is evident from figures 7 and 9, the first clamp section 106 and the second clamp section 108 are arranged close to the sensor hole 110 and are provided on the downstream side of the first sensor 40 and the second sensor 42 .

[0071] As shown in figures 10A to 10C, the first clamp section 106 has a closing section (compression section) 122, which is provided as part of the first passPetition 870190089390, of 10/09/2019, pg. 25/57

19/42 guide gem 112 in a portion on the first side of the circumferential direction B1 of an inner circumferential end of the plate section 100 and which closes the first tube 60, a tongue section 124 to support the closing section 122 during closing and a triangular protrusion 126 provided on a surface on an opposite side from the closing section 122. [0072] The closing section 122 has an enlarged portion (compression portion) 128 for compressing the first tube 60 from a side portion thereof and a sharp-angled engagement portion 130 provided at the tip of the enlarged portion 128. A base portion of the closing section 122 is formed of a sufficiently small diameter, so that the enlarged portion 128 can be elastically advanced and retracted substantially in the radial direction. The tongue section 124 has an engaging portion 132 for engaging with the engaging portion 130 of the enlarged section 128 in a compression state of the first tube 60 and an inclined surface 134 formed at the tip thereof. A direction perpendicular to the inclined surface 134 is oriented towards an inclined inner side. Due to the presence of the inclined surface 134, the tongue section 124 has a tapered shape when viewed in plan. The tongue section 124 is formed with a sufficiently small diameter in the base portion thereof and can be elastically inclined.

[0073] The first clamp section 106 is thus simply configured. In addition, the first clip section 106 is formed by integral molding with the cassette 50a, so that it is unnecessary to provide the clip as an independent component part and a reduction in the number of component parts can be obtained.

[0074] As shown in figure 10A, in the initial condition of the first clip section 106, the enlarged portion 128 of the

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20/42 closure 122 is separated from the first tube 60, whereby the first tube 60 is placed in a conduction state.

[0075] As shown in figure 10B, when the first stem

136 of the central body 14a is extended to compress the closing section 122 from a side portion and displacing the closing section 122, the enlarged portion 128 compresses the first tube 60 in cooperation with the projection 126, in order to close the first tube 60. In this case, the engaged portion 130 engages with the engaging portion 132 slidably tilting the tongue section 124. Thereafter, the closed state of the first pipe 60 by the enlarged portion 128 is maintained, even after the first stem 136 return to its original position.

[0076] As shown in figure 10C, when the second stem

138 is extended, its tip surface slides over the inclined surface 134 and pushes outwardly towards a side portion and the tongue section 124 is inclined, whereby the engaging portion 132 becomes detached from the engaged portion 130 and the docked state is released. Therefore, when the second rod 138 contracts to its original position, the first clamp section 106 is returned to the initial state shown in figure 10A and the first tube 60 is returned to a conduction state.

[0077] Since the second clip section 108 is symmetrical with the first clip section 106, detailed description of the same is omitted. By means of the second clamp section 108, the second tube 62 can be closed and opened. When the blood bag system 10a is mounted on the centrifuge and separation device 11, the first clip section 106 and the second clip section 108 are operated by the first clip drive means 17a and the second clip drive means 17b of the central body 14a (see figure 2). When the blood bag system 10a is not fitted

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21/42 do, the first clip section 106 and the second clip section 108 can be operated manually.

[0078] As shown in figures 7 and 8, the filter holder

104 has a hinge section 140, a connection 142 and a pipe fitting section 144.

[0079] As shown in figure 11, the hinge section 140 is basically composed of a pair of flap pieces 146 opposite each other in the circumferential direction and a vertical wall (retainer) 148 provided on the side of the base end. A thin protrusion 150 projects in the direction of the outside diameter from the lower end of the vertical wall 148. The vertical wall 148 allows the filter 56 to be adapted at a more precise angle.

[0080] The pair of flap pieces 146 is provided on the inner sides of it with a pair of round shafts 152 which are opposite each other above the projection 150, a pair of small upper retainers 154 provided in the upper end portions above the outside diameter side and a pair of small sliding projections 156 provided in lower portions. As is evident from figure 11, the round shafts 152 are constituted by shafts that extend in the circumferential direction, so that the filter 56 can be tilted with reference to the round shafts 152.

[0081] As shown in figure 12, since the round shafts 152 are provided in upper portions of the flap parts 146, it is possible to move the filter 56, the outlet 56b and the connection 142 to appropriately high positions in their expanded state. Also, when the set is placed on a table surface, such elements exert their own weights on the BC 54 collection bag and excessive pressure is not exerted on the BC 54 collection bag.

[0082] As shown in figure 13, connection 142 has a

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22/42 support plate 158, which makes contact with and thus supports a lateral surface in the longitudinal direction, as well as half of the upper portion and half of the lower portion of the filter holder 104, a hinge bearing section 160 having a sectional shape similar to a semicircular arc that fits with the round shafts 152 and an arm 162 that connects to an end portion of the support plate 158 and the hinge bearing section 160. The arm 162 includes a quadrilateral hole 164, into which the protrusion 150 is snugly inserted and left and right reinforcement plates 166.

[0083] The support plate 158 includes a pair of filter support projections 168 provided on the internal surface in order to support both surfaces of the filter 56, the tube support projections 170 provided on the external surface in order to maintain the first tube 60 in three positions, a first semicircular notch portion (first fitting portion) 172 provided in an upper tip portion for fitting the inlet 56a therein and a second semicircular notch portion (second fitting portion) 174 provided in a lower base end portion for adapting the outlet 56b therein. In a curved condition, the first semicircular notch portion 172 is arranged on the outside diameter side with respect to the second semicircular notch portion 174.

[0084] When connection 142 is adapted to the hinge section

140, the hinge bearing section 160 with the arm 162 directed downwards is adapted on the round shafts 152 from a lateral portion and, after that, the connection 142 is pushed by exerting some force on it, as it allows arm 162 slides over upper retainers 154. Thus, connection 142 is easily assembled in position.

[0085] Incidentally, hinge section 140 is not limited

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23/42 gives a configuration similar to an axis based on the round axes 152. For example, a configuration can also be adopted in which a thin section or an elastic section is curved.

[0086] A tube fitting section 144 is provided in a portion adjacent to the hinge section 140 of the arc section 102 to thereby maintain the second tube 62 in an appropriate orientation.

[0087] According to filter holder 104, filter 56 can be stably supported by connection 142 and the first tube 60 and the second tube 62 can be suitably supported by the tube support projections 170 and the tube fitting section 144.

[0088] Furthermore, when the hinge bearing section 160 is pivotally supported on the round shafts 152, the connection 142 and the filter 56 can be tilted in several states, including an expanded state (see figure 7) in which the connection 142 and filter 56 are parallel to and substantially in the same plane as cassette 50a and a curved state (see figure 8) in which connection 142 and filter 56 are curved at an angle of 90 ° with respect to cassette 50a.

[0089] In the expanded (dispersed) state in which the connection 142 and the filter 56 are substantially on the same plane as the cassette 50a, further rotation of these is prevented by the upper retainers 154. Since the upper retainers 154 are sufficiently small, however, connection 142 and filter 56 can be rotated beyond the upper retainers 154, if necessary, by exerting an appropriate force on them.

[0090] In the condition where the connection 142 and the filter 56 are curved at 90 ° with respect to the cassette 50a, a lateral surface of the arm 162 makes surface contact with the vertical wall 148, whereby a guaranteed angular positioning is obtained. In this case, the projection 150

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24/42 is inserted in the quadrilateral hole 164, so that the stability of connection 142 is enhanced. In addition, when an operation is performed to bend connection 142, both side portions of connection 142 slide over the sliding projections 156 and an appropriate fit sensation is obtained. Therefore, the operator can recognize that connection 142 has been adapted at an appropriate angle.

[0091] The tip of the projection 150 can be of a wide diameter, so that a more secure fit sensation is produced when the projection 150 is inserted into the quadrilateral hole 164 and so that the projection 150 is prevented from sliding.

[0092] According to the filter holder 104 mentioned above, in times of storage and transport of the blood bag system 10a and the like, placing the connection 142 and the filter 56 in an expanded state substantially on the same plane as the cassette 50a , the set is made thin enough. Consequently, the set can be placed in a vinyl resin bag or similar, along with (for example, in a state of being stacked with) the BC 54 collection bag and the platelet conservation bag 58. Although such a packaged state -in-bag is not shown in the drawings, it is evident from figure 4 that the blood bag system 10a may be contained in a folded state inside a vinyl resin bag, which is slightly larger than the bag conservation of platelet 58 that makes up the largest component parts in the area.

[0093] Also, when buffy coat platelets are introduced into the BC 54 collection bag from a required number of BC 72 bags, placement of connection 142 and filter 56 in an expanded state substantially on the same plane as the cassette 50a, it is ensured that the system does not expand unnecessarily and the system can be easily hung on a belt support.

[0094] On the other hand, it is preferable that filter 56 is preliminary

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25/42 in the regulated orientation when put into use. Specifically, so that white blood cells are removed by the filter 56, the flow direction is configured so that the blood component is supplied through inlet 56a and is guided through outlet 56b.

[0095] According to the filter holder 104, when the blood bag system 10a is mounted on the centrifuge and separation device 11, the system is used in a condition where connection 142 and filter 56 are curved at 90 ° with respect to cassette 50a. In addition, as shown in figure 8, filter 56 is maintained so that outlet 56b is on a proximal side with respect to hinge section 140, while inlet 56a is on a distal side with respect to hinge section 140 Thus, filter 56 is used in a condition where the flow direction is oriented against the centrifugal force. As a result, the supernatant liquid 176 flows against the centrifugal force in the filter 56, whereby the flow rate is suppressed appropriately and white blood cells can be safely removed.

[0096] Furthermore, since inlet 56a is located below and on the outside diameter side with respect to outlet 56b, the supernatant liquid 176 that flowed through inlet 56a initially collects in a lower portion of the interior of filter 56 , on the outer side of a filter medium 57 (see figure 14) disposed in the filter 56 and dispersed in the lumen of the filter 56 along a surface on the outside diameter side while the centrifugal force acts on it. After the space on the outside of the filter medium 57 is filled, the supernatant liquid 176 is filtered as it passes through the filter medium 57 and is discharged through the outlet 56b. Therefore, the supernatant liquid 176 is filtered while effectively using the entire surface of the filter medium 57 within the filter 56. Consequently, speed 870190089390, of 10/09/2019, pg. 32/57

26/42 white blood cells can be removed more safely. [0097] In addition, when mounting the filter holder

104, the orientation of the filter 56 is determined by the first semicircular notch portion 172, in which the inlet 56a is adapted and the second semicircular notch portion 174, in which the outlet 56b is adapted, so that erroneous assembly can prevent . [0098] The following is a method of using the blood bag system

10a and cassette 50a according to the first embodiment configured in the preceding manner will be described below.

[0099] First, as shown in figure 5, clamp 84 over the third tube 70, the first clamp section 106 and the second clamp section 108 are closed. A required number of BC 72 bags are connected to the branch tube 74 and the container 68 for the platelet preservation liquid is connected to the third tube 70. White blood platelet layers (or whole blood) collected from different donors are collected in the blood bags. BC 72, respectively. Then, the buffy-coat layers are collected from the BC 72 bags to the BC 54 collection bag.

[00100] Then, on the third tube 70, the clip 82 is closed while the clip 84 is opened, whereby the platelet preserving liquid is transferred to the BC 72 bags and the platelet preserving liquid is mixed with the remaining buffy coat layers in BC 72 bags.

[00101] In addition, clip 84 is closed and clip 82 is opened, whereby the buffy coat layers mixed with the platelet preservation liquid are transferred to the BC 54 collection bag.

[00102] The BC 54 collection bag is compressed manually, so the air inside the BC 54 collection bag is transferred to the BC 72 bags.

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27/42 [00103] Then, the third tube 70 is cut, after being melted and sealed in an anti-leakage manner, in a position close to the BC 54 collection bag. The remaining portion forms a third short tube 70a, as shown in Figure 7 and the third tube 70a is fixed in the auxiliary fixing section 116, so that the tip of it is oriented in the centrifugal direction. The third tube 70a can be cut shorter than that shown in figure 7.

[00104] Subsequently, as shown in figure 8, connection 142 and filter 56 are curved at 90 ° with respect to cassette 50a. Filter holder 104 acts to precisely and steadily maintain connection 142 and filter 56 in a 90 ° curved state. Consequently, as mentioned above, inlet 56a is located below and on the outside diameter side with respect to outlet 56b when connection 142 and filter 56 are curved 90 ° with respect to cassette 50a, the flow rate is suppressed and the entire surface of the filter medium 57 within the filter 56 is effectively used.

[00105] Furthermore, as shown in figure 3, the blood bag system 10a is mounted on the insertion unit 18. Specifically, the cassette 50a is mounted on the cassette holder 38 and supported by the support projections 45, the pouch BC collection 54 is inserted into small chamber 30, filter 56 and filter holder 104 are inserted into filter bag 36 and platelet preservation bag 58 and sampling bag 76 are inserted into large chamber 32. Incidentally, since the filter 56 is kept very stably in a state of being bent at 90 ° by the filter holder 104, a configuration in which the filter bag 36 is omitted and the filter 56 and the filter holder 104 are held in the chamber large 32, can also be adopted, depending on the design conditions.

[00106] In this case, as shown in figure 9, the first tube

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28/42 and the second tube 62 are suitably arranged in the hole for sensor 110. Therefore, the first tube 60 is suitably trapped between the light emitting section 40a and the light receiving section 40b of the first sensor 46, while the second tube 62 is suitably trapped between the light emitting section 42a and the light receiving section 42b of the second sensor 42. Naturally, the first tube 60 is not arranged in a detection position of the second sensor 42 and the second tube 62 is not arranged in a detection position of the first sensor 40.

[00107] The arc section 102 is stabilized by support and assembly thereof on the upper terminal surface of the wall 34, so that the connection 142 and the filter 56 suspended from the arc section 102 also become stable.

[00108] In addition, the BC 54 reserve bag is supported by the two pins 118, while the first tube 60 connected to the BC 54 collection bag is attached along the first guide passage 112. Therefore, the first tube 60 it is arranged and oriented in the direction of internal diameter A2, as seen from the BC collection bag 54.

[00109] Then, as shown in figure 1, the insertion unit 18, with the blood bag system 10a inserted therein, is inserted into the insertion hole of unit 16 of the centrifuge and separation apparatus 11. As a result , an end portion of the cassette 50a is secured by the containment lever 25 (see figure 2). In addition, the contacts of the first sensor 40 and the second sensor 42 or their interface circuits are placed in contact with the electrodes 27 (see figure 2).

[00110] Although six insertion units 18 are basically mounted on the centrifuge and separation apparatus 11, the number of insertion units 18 can be five or less, as long as the

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29/42 insertion units 18 are in balance (preferably three or two at regular angular intervals).

[00111] When the insertion unit 18 is inserted into the unit insertion hole 16, the first clip section 106 and the second clip section 108 are suitably arranged in corresponding positions opposite the first clip drive means 17a and the second clip drive means 17b (see figure 2), respectively. Once the first tube 60 and the second tube 62 are preliminarily properly arranged by the first guide passage 112 and the second guide passage 114 in relation to the first clip section 106 and the second clip section 108, the first clip section 106 and the second clip section 108 can be suitably closed and opened via the first clip section 106 and the second clip section 108 under the action of a microcomputer.

[00112] Thus, in a series of operations by which the blood bag system 10a and cassette 50a are assembled, each of the tubes in the blood bag system 10a is preliminarily connected properly. Specifically, by means of the first guide passage 112 and the second guide passage 114 in cassette 50a, the first tube 60 and the second tube 62 are suitably arranged with respect to the sensor hole 110, the first clip section 106 and the second section of clamp 108. Therefore, no special knowledge or understanding of the operator is required regarding the operations and procedures for configuring the tubes, so the operator can easily and quickly assemble the blood bag system 10a, without the possibility of erroneous assembly. The first tube 60 and the second tube 62 are preliminarily properly arranged within the cassette 50a. In practice, therefore, the operator will be able to mount the blood bag system 10a on the

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30/42 centrifugation and separation without using manuals or the like. [00113] Then, the cover 12 of the centrifugation and separation apparatus 11 is closed, at which time a centrifugation step and a separation step (a transfer step) are performed by operating the console section 22.

[00114] During an automatic operation of the centrifugation and separation apparatus 11, first, the centrifugal drum 14 is rotated to carry out the centrifugation step. In this case, the first clip section 106 and the second clip section 108 are preliminarily closed. To enhance operational safety, however, as shown in figure 10B, the first rod 136 is initially extended, so that the first clip section 106 is placed in a flat state by the closing section 122. The second clip section 108 it is also placed in a closed state in the same way.

[00115] As shown in figure 14, during the centrifugation step, a centrifugal force is given to the buffy coat layer preserved in the BC 54 collection bag inside the small chamber 30. As a result, the sedimentary liquid 178 containing components of heavy and similar blood cells are moved in the direction of the outer diameter, while the supernatant liquid 176 containing light and similar platelet components is moved in the direction of the inner diameter, whereby the liquids become separated from each other. Supernatant liquid 176 contains white blood cells. Sedimentary liquid 178 has a deep red color and low transparency, while liquid 176 consists of a slightly yellow-white transparent matter.

[00116] The centrifugation and separation apparatus 11 leaves the centrifugation stage for the separation stage.

[00117] During the separation step, while the centrifugal drum

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31/42 go 14 continues to rotate, the second stem 138 is extended once, as shown in figure 10C, in order to tilt the tongue section 124 and release the locked state, thereby returning the centrifuge and separation apparatus 11 to the initial condition shown in figure 10A and placing the first tube 60 in an open state. The second tube 62 is also placed in an open state in the same way.

[00118] Then, as shown in figure 14, the compressor 20 is moved in the centrifugal direction A1 in order to compress the BC 54 collection bag. The internal volume of the BC 54 collection bag is reduced while being trapped between the compressor 20 and the wall 34, whereby the liquid contained in it is discharged through the first tube 60. In this case, inside the BC collection bag 54, the sedimentary liquid 178 is collected in the direction of the outside diameter, while the supernatant liquid 176 is collected in the direction of the inner diameter. Meanwhile, the first tube 60 is oriented in the direction of the inner diameter, so that only the supernatant liquid 176 is ejected into the first tube 60.

[00119] The supernatant liquid 176 that is ejected into the first tube 60 flows to the location of the first section of clip 106, which is in an open state, when the white blood cells are removed from it by filter 56. In this case , since the filter 56 is configured so that the inlet 56a is located below and on the outside diameter side with respect to the outlet 56b, the supernatant liquid 176 flows in a direction resistant to gravity and centrifugal force. Therefore, the flow rate of the supernatant liquid 176 is suppressed and removal of white blood cells can be achieved safely through effective use of the entire surface of the filter medium 57. The supernatant liquid 176 which has passed through the filter 56 flows back to the location of the second clamp section 108, the

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32/42 which is in an open state and is supplied in and collected within the platelet conservation pouch 58.

[00120] It is desirable that the supernatant liquid 176 in the BC 54 collection bag be transferred to the platelet conservation bag 58 as completely as possible. However, it is undesirable for sediment liquid 178 to be transferred to the platelet conservation bag 58. In view of this, the liquids that pass through the first tube 60 and the second tube 62 are monitored by the first sensor 40 and the second sensor 42 and a control is carried out in order to prevent the sedimentary liquid 178 from being transferred to the platelet conservation bag 58.

[00121] Specifically, the microcomputer monitors signals supplied from the first sensor 40 and the second sensor 42, determines transparency values of the liquids that pass through the first tube 60 and the second tube 62 based on the magnitudes of the signals and distinguishes the supernatant liquid 176 and the sedimentary liquid 178 from each other by their respective transparencies.

[00122] When the BC 54 collection bag is compressed by the compressor 20 during the separation step, the supernatant liquid 176 is oriented out of the first tube 60 in an initial period, so that it can be confirmed by the first sensor 40 and by the second sensor 42 that the supernatant liquid 176 is flowing in them due to the transparency of the liquid.

[00123] While the compression of the BC 54 collection bag by the compressor 20 is continued, the supernatant liquid 176 in the BC 54 collection bag flows completely and, after that, the sediment liquid 178 is oriented outwards. As a result, the first sensor 40 detects that the liquid flowing through the first tube 60 has changed to the sedimentary liquid 178.

[00124] At that point in time, the separation step can be

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33/42 considered finished. In order to collect the platelets in the platelet conservation bag 58 as much as possible, however, it is desirable that portions of the supernatant liquid 176, which remains in the first tube 60 and the second tube 62, are also fed to the platelet conservation bag 58. From this point of view, after the sedimentary liquid 178 has been detected by the first sensor 40, compression of the compressor 20 can be further continued for a predetermined period of time.

[00125] Then, when a predetermined period of time has elapsed or when it has been detected by the second sensor 42 that the liquid flowing through the second tube 62 has changed to sedimentary liquid 178, the first rods 136 are extended (see figure 10B) of in order to close the first clip section 106 and the second clip section 108, thereby placing the first tube 60 and the second tube 62 in a closed state. In addition, the centrifugal drum 14 is stopped, at which point the separation step is completed.

[00126] When a predetermined period of time has elapsed since the detection of sedimentary liquid 178 by the first sensor 40, the sedimentary liquid 178 reaches the filter 56 and portions of the supernatant liquid 176 which remain in the first tube 60 and the second tube 62 are fed to the platelet conservation bag 58 accordingly. Incidentally, before the predetermined period of time has elapsed, basically, the sedimentary liquid 178 will not reach the position of the second sensor 42 (i.e., the position of the hole for sensor 110). In order to prevent the sedimentary liquid 178 from mixing in the platelet conservation bag 58, however, monitoring of it by the second sensor 42 is performed.

[00127] Immediately upon detection, by the second sensor 42, transfer of sedimentary liquid 178 to the second tube 62, the first section of clamp 106 and the second section of clamp

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34/42

108 are simultaneously placed in a closed state in order to prevent the sediment liquid 178 from flowing further downstream. There is a slight time delay until the first clamp section 106 and the second clamp section 108 become completely closed after detection of the sediment liquid 178 by the second sensor 42. In the course of the second tube 62, however, the second clamp section 108 is located on a downstream side with respect to the position of the hole for sensor 110, where the second sensor 42 is provided. Therefore, sediment liquid 178 does not flow downstream of the second clamp section 108. Even if sediment liquid 178 flows to the position of the second clamp section 108, sediment liquid 178 will not reach the platelet conservation pouch 58 because a certain distance is provided between the position of the second clamp section 108 and the platelet conservation pouch 58.

[00128] When the separation step is completed and the centrifugal drum 14 is completely stopped in this way, the cover 12 is opened. The insertion units 18 are removed by operating the containment levers 25 and the blood bag systems 10a are removed by loosening the cover bodies 28. In that case, the cassette 50a can be easily released from the cassette holder 38 simply by operating the levers separator 44 (see figure 3).

[00129] Also, the first tube 60 in the blood bag system 10a is cut after being fused in a position close to the BC 54 collection bag, so the BC 54 collection bag serves as a blood product containing components of blood cells. On the other hand, when the second tube 62 is cut after being melted in a position close to the platelet conservation pouch 58, the platelet conservation pouch 58 serves as a blood product containing platelets. The blood product from the platelet conservation bag 58 allows part of it to be transferred to the

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35/42 sample bag 76 and would serve for a predetermined test or similar.

[00130] According to the blood bag system 10a and cassette 50a of the first embodiment, as mentioned above, cassette 50a has the first tube 60 and the second tube 62 preliminarily appropriately arranged in it, so that it is sufficient simply mount the cassette 50a on the central body 14a of the centrifuge and separation apparatus 11. Therefore, the need for layer formation and intricate configuration of the first tube 60 and the second tube 62 is eliminated and assembly can be carried out easily and safely. In addition, cassette 50a includes the first staple section 106 and the second staple section 108, which are suitably arranged with respect to the first staple drive means 17a and the second staple drive means 17b within the centrifuge and separation 11.

[00131] Furthermore, by operating the hinge section 140, which is inclinable with reference to an axis in the circumferential direction (the direction of arrow B), connection 142 and filter 56 can be configured in different appropriate orientations, respectively , in a moment of storage and in a moment of use.

[00132] In the blood bag system 10a, in the expanded state (see figure 7), the cassette 50a, the plate section 100 and the arc section 102 are arranged in parallel, so that they can be made sufficiently thin during storage and can be folded into a thin form together with the BC 54 collection bag, the platelet conservation bag 58 and the like. Also, in the curved state (see figure 8), the filter 56 can be arranged in an appropriate 90 ° curved orientation, while the first tube 60 and the second tube 62, which are mounted on the plate section 100, are maintained in a horizontal state.

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36/42 [00133] Since the connection 142 supports the filter 56 in such a way that the outlet 56b is on a side proximal with respect to the hinge section 140, while the inlet 56a is on a distal side with respect to the section of hinge hinge 140, in the curved state, it is possible to configure the inlet 56a on the lower side and the outlet 56b on the upper side.

[00134] Since connection 142 supports inlet 56a on the outside diameter side and outlet 56b on the inside diameter side in the curved state, filter 56 can be used in an appropriate orientation.

[00135] Since the arc section 102 is provided on the outside diameter side in relation to the plate section 100 and forms the hole for bag 105, into which the BC 54 collection bag is inserted, it is possible to arrange the connection 142 and the filter 56 on the outside diameter side and arrange the BC 54 collection bag on the inside diameter side. In the centrifugation and separation apparatus 11, the BC 54 collection bag is compressed by the compressor 20 during the separation step, which occurs after the centrifugation step. In view of this, it is preferable that the BC 54 collection bag is on the inside diameter side, as mentioned earlier.

[00136] Furthermore, since the arc section 102 is formatted along the upper terminal surface of the wall 34, there is no unnecessary roughness in relation to the wall 34 and the connection 142 and the filter 56 can be arranged directly on the outside of the wall 34, so that efficient use of space is obtained. In addition, when mounted on the upper surface of the wall 34, the arc section 102 becomes more stable.

[00137] Cassette 50a is attached to the centrifugation and separation apparatus 11 so that the first tube 60 and the second tube 62 are partially configured horizontally and oriented in the direction

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37/42 radial and so that blood components within the tubes flow in the direction of the inner diameter. In these parts, blood components flow against the centrifugal force, so that their flow rates can be prevented from increasing excessively.

[00138] The blood bag system 10a and cassette 50a are inexpensive configurations, which are suitable for disposable use.

[00139] The assembly, packaging and sterilization treatment of the blood bag system 10a are performed under a quality control predetermined by the manufacturer. The blood bag system 10a is assembled by a predetermined automatic machine or is assembled manually using predetermined mounting templates. In addition, tests are preliminarily conducted by predetermined automatic testing equipment, so a precise configuration can be achieved.

[00140] Next, a blood bag system 10b and a cassette 50b according to a second embodiment will be described below. Components of the blood bag system 10b (and 10c) and cassette 50b (and 50c), which are the same as those of the blood bag system 10a and cassette 50a described above, are denoted by the same reference characters used above and detailed descriptions of such characteristics are omitted.

[00141] The blood bag system 10b includes cassette 50b and a multiple bag 52. The multiple bag 52 is basically the same as that used in the blood bag system 10a, except that a first tube 60 and a second tube 62 are provided together with a first clamp 200 and a second clamp 202.

[00142] As shown in figures 15 and 16, instead of the first clamp section 106 and the second clamp section 108 described above (see figure 4), the blood bag system 10b has the

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38/42 first clamp 200 and second clamp 202, as well as a first clamp operating section 204 and a second clamp operating section 206 for operating and placing the first clamp 200 and the second clamp 202 in closed and open states.

[00143] The first clamp 200 and the second clamp 202 comprise the means for closing and opening intermediate portions of the first tube 60 and the second tube 62, similar to the first clamp section 106 and second clamp section 108 described above.

[00144] As shown in figure 17, the first clamp 200 is a resin body provided, at one end of it, with a tongue section 200a, which is short and curved back in a J shape and provided, in the another end of it, with a closing section (compression section) 200b, which is a little longer and curved back in a U shape. The first clamp 200 is also provided, on an internal surface of the same, with a projection 200c and at both ends of it with holes in which to insert the first tube 60.

[00145] The projection 200c is located in a position slightly offset from the center and has a hole 200f in it. In an initial state, the closing section 200b is open to an appropriate degree.

[00146] The tongue section 200a, the closing section 200b and the projection 220c correspond, respectively, to the tongue section 124, to the closing section 122 and to the projection 126 described above (see figure 10A). More specifically, when the closing section 200b is pushed towards the inside, the first tube 60 can be closed by an enlarged portion 200d on the inside of the closing section 200b and the projection 200c, while the closing section 200b is maintained by the tongue section 200a.

[00147] When an inclined surface 200e at the tip of the section

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39/42 of tongue 200a is pushed towards a lateral portion (or if the inclined surface 200e is pushed by a rod or the like from a lateral portion) and the tongue section 200a is thus inclined towards the side portion, the closing section 200b is released from an engaged state and returns to its original position, thereby opening the first tube 60.

[00148] The second clamp 202 has the same structure as the first clamp 200. As for the first clamp 200 and the second clamp 202, the same structures as in clamps 82, 84, 86, 88 above can be used.

[00149] The first clamp operation section 204 in cassette 50b includes a first compression section 208 for pushing into the closing section 200b by operating a first rod 136 and a second compression section 210 that slides over an inclined surface 200 and by means of operation of a second stem 138, in order to incline the tongue section 200a towards a lateral portion.

[00150] The first compression section 208 and the second compression section 210 are tuned in the vicinity of the base end portions thereof so as to have elasticity and the first compression section 208 and the second compression section 210 can be elastically displaced substantially in the radial direction under operations of the first rod 136 and the second rod 138. The end faces on one side of the inner diameter of the first compression section 208 and the second compression section 210 are formed as substantially external flat surfaces 208a and 210a along from the circumferential direction, so that such end faces are stably compressed by the first stem 136 and the second stem 138.

[00151] The first section 208 is provided with a flat inner surface 208b substantially along the circumferential direction, of

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40/42 so as to be able to easily compress a portion of the inside diameter side of a tip portion of the closing section 200b. The second compression section 210 is provided with an inclined surface 210b, which is suitable for sliding along the inclined surface 200e and the tongue section 200a.

[00152] The first clamp operation section 204 is provided with a space for clamp 212 in which the first clamp 200 is held, while leaving a small gap. The clamp space 212 is shaped so that the first clamp 200 cannot be mounted therein in an erroneously deflected position or in an inverted orientation. Specifically, the space for clamp 212 is provided with a projection (columnar section) 201 which is inserted into hole 200f, whereby positioning of the first clamp 200 is obtained. Since the projection 200c and the hole 200f are each located in a position highly offset from the center, there is no possibility that the first clamp 200 will be mounted in an inverted orientation. Within the space for clamp 212, a gap is maintained, which allows the tongue section 200a to be tilted towards a side portion.

[00153] The second clamp operation section 206 is symmetrical in shape with the first clamp drive section 204. The first clamp operation section 204 and the second clamp operation section 206 can be operated, respectively, by the first staple drive means 17a and the second staple drive means 17b (see figure 2) and can be operated manually when the blood bag system 10b is not mounted inside the centrifuge and separation apparatus 11.

[00154] A first guide passage 112 and a second guide passage 114 in cassette 50b of the blood bag system 10b are shorter than those in the blood bag system 10a des

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41/42 above. The first guide passage 112 and the second guide passage 114 are formed so as to extend through the upper portions of a sensor hole 110 to thereby orient the first tube 60 in a first circumferential direction B1 and the second tube 62 in a second circumferential direction B2.

[00155] In the blood bag system 10b and the cassette 50b configured as described above, the first tube 60 and the second tube 62 are preliminarily properly arranged, similar to the blood bag system 10a and cassette 50a described above. Therefore, it is sufficient that the cassette 50b is mounted inside the central body 14a of the centrifugation and separation apparatus 11 and the need for layer formation and intricate configuration of the first tube 60 and the second tube 62 is eliminated, so that assembly of the same can be performed easily and safely. In addition, cassette 50b includes the first clamp 200, the second clamp 202, the first clamp operating section 204 and the second clamp operating section 206, with such components being arranged appropriately with respect to the first clamp driving means 17a and the second clip driving means 17b (see figure 2) of the centrifugation and separation apparatus 11.

[00156] In the blood bag 10b and cassette 50b system, conventionally used general purpose clamps can be applied to the first clamp 200 and the second clamp 202 configured so that the operator can easily compress the clamp medium during manual operation of the same . In addition, in the case where the multiple pouch 52 can be released from the cassette 50b for some reason, the first tube 60 and the second tube 62 can be held close by the first clip 200 and the second clip 202.

[00157] As shown in figure 18, a blood bag system 10c and a cassette 50c according to a third embodiment

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42/42 have respective configurations, which are obtained by omitting the first clamp operation section 204 and the second clamp operation section 206 of the blood bag system described above 10b and cassette 50b. In that case, it is recommended that the first rods 136 and second rods 138 have forward and retract amounts and tip shapes specified in accordance with the closing section 200b and the tongue section 200a of the first clamp 200 and the second clamp 202 and that the first rods 136 and the second rods 138 are driven directly by a first clip driving means 17a and a second clip driving means 17b.

[00158] Blood bag systems 10a to 10c and cassettes 50a to 50c are applicable not only to a centrifuge and separation device 11, but also to a blood component collection device, a whole blood collection device, an automatic blood separation device, etc. The liquid preserved in the BC 54 collection bag is not limited to a buffy coat and, depending on its use, whole blood (liquid contained) can be preserved in it.

[00159] The blood bag system and the cassette according to the present invention are not limited to the modalities described above and, of course, various configurations can be adopted without deviating from the essence and foundation of the invention.

Claims (10)

1. Blood bag system (10a, 10b, 10c) characterized by the fact that it comprises: a first pouch (54) for collecting whole blood or a blood component; a filter (56) having a filter means (57) for removing predetermined cells from a blood component obtained by centrifuging the liquid contained in the first pouch (54); a second bag (58) for collecting a blood component obtained when removing the predetermined cells by the filter (56); a first tube (60) for connecting the first bag (54) and a filter inlet (56); a second tube (62) for connecting the second bag (58) and a filter outlet (56); and a cassette (50a, 50b, 50c) having a plate section (100) for supporting a portion of the first tube (60) and a portion of the second tube (62), wherein the cassette (50a, 50b, 50c) includes a connection (142) supporting and directly contacting the filter (56), the cassette (50a, 50b, 50c) including a hinge section (140), through which the connection (142) is connected to the plate section (100) in an inclinable way. 2. Blood bag system (10a, 10b, 10c) according to claim 1, characterized by the fact that the hinge section (140) is inclinable to assume several states, including an expanded state in which the connection ( 142) or the filter (56) is located on the same plane as the plate section (100) and a curved state in which the connection (142) or the filter (56) is inclined substantially perpendicular to the plate section (100). Petition 870190089390, of 10/09/2019, p. 50/57 2/4 3. Blood bag system (10a, 10b, 10c) according to claim 2, characterized by the fact that the hinge section (140) has a retainer (148) by which the angle of inclination of the connection (142 ) or the filter (56) with respect to the plate section (100) is substantially restricted at a right angle. 4. Blood bag system (10a, 10b, 10c) according to claim 2, characterized by the fact that the filter (56) has a shape similar to the plate having a first surface and a second surface on an opposite side and is provided with an inlet (56a) on the first surface side at one end of it and an outlet (56b) on the second surface side at the other end of it, and the connection (142) holds the filter (56) so that, in the curved state, the inlet (56a) is located on an external side and the outlet (56b) is located on an internal side. 5. Blood bag system (10a, 10b, 10c), according to claim 2, characterized by the fact that the connection (142) has a first fitting portion (172) in which the inlet (56a) of the filter (56) is adapted and a second adaptation portion (174) in which the outlet (56b) of the filter (56) is adapted, and in the curved state, the first adaptation portion (172) is located on an external side with respect to to the second adaptation portion (174). 6. Blood bag system (10a, 10b, 10c) according to claim 1, characterized by the fact that the connection (142) holds the filter (56) so that the outlet (56b) of the filter (56 ) is on a proximal side with respect to the hinge portion (140), while the inlet (56a) of the filter (56) is on a distal side with respect to the hinge portion (140). 7. Blood bag system (10a, 10b, 10c), according to Petition 870190089390, of 10/09/2019, p. 51/57 3/4 with claim 1, characterized by the fact that the cassette (50a, 50b, 50c) includes an arc section (102) for forming a pocket hole (105) into which the first pocket (54) is inserted on the outer side with respect to the plate section (100) and the hinge section (140) is arranged in the arc section (102). 8. Blood bag system (10a, 10b, 10c), according to claim 1, characterized by the fact that whole blood or a blood component collected from a plurality of donors is collected in the first bag (54), and in that the blood bag system is mounted on a centrifugation and separation device (11) for centrifuging the liquid contained in the first bag (54) in a supernatant liquid and a sedimentary liquid, removing a predetermined component of the supernatant liquid by the filter ( 56) and transfer of the supernatant liquid, devoid of the predetermined component, to the second bag (58). 9. Blood bag system (10a, 10b, 10c) according to claim 8, characterized by the fact that the centrifugation and separation device (11) includes a first sensor (40) and a second sensor (42) , each of which has a section that emits light (40a, 42a) and a section that receives light (40b, 42b) and which detects the type of liquid that passes between the section that emits light (40a, 42a) and the section receiving light (40b, 42b), the cassette (50a, 50b, 50c) has a sensor hole (110) into which the first sensor (40) and the second sensor (42) are inserted, and the first tube ( 60) is located in order to pass between the light emitting section (40a) and the light receiving section (40b) of the first sensor (40), while the second tube (62) is located in order to pass between the section emitting light (42a) and the light receiving section (42b) of the second sensor (42). Petition 870190089390, of 10/09/2019, p. 52/57 4/4 10. Cassette (50a, 50b, 50c), characterized by the fact that it is mounted on a multiple bag and comprises: a first pouch (54) for collecting whole blood or a blood component; a filter (56) having a filter means (57) for removing predetermined cells from a blood component obtained by centrifuging the liquid contained in the first pouch (54); a second pouch (58) for storing a blood component obtained when removing the predetermined cells by the filter (56); a first tube (60) connecting the first bag (54) and a filter inlet (56); and a second tube (62) connecting the second bag (58) and a filter outlet (56), wherein the cassette (50a, 50b, 50c) includes a first guide passage (112) which is positioned in part of the first tube (60) so that the part of the first tube (60) is held in the first guide passage (112) and a second guide passage (114) which is positioned in a part of the second tube (62) so that the part of the second tube (62) is held in the second guide passage (114), the cassette (50a, 50b, 50c) further including a connection (142) supporting the filter (56) and a hinge section (140) through which the connection ( 142) is tiltably connected to the plate section (100).